Who is the manufacturer of CHASE RETROGRADE CARDIOPLEGIA CANNULA?

Chase Medical, Inc. filed the 510(k) submission for CHASE RETROGRADE CARDIOPLEGIA CANNULA (K964393).

What is the FDA product code for CHASE RETROGRADE CARDIOPLEGIA CANNULA?

DWF. It is classified under 21 CFR 870.4210 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for CHASE RETROGRADE CARDIOPLEGIA CANNULA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHASE RETROGRADE CARDIOPLEGIA CANNULA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHASE RETROGRADE CARDIOPLEGIA CANNULA

K964393 · Chase Medical, Inc. · DWF · Apr 23, 1997 · Cardiovascular

Device Facts

Record ID	K964393
Device Name	CHASE RETROGRADE CARDIOPLEGIA CANNULA
Applicant	Chase Medical, Inc.
Product Code	DWF · Cardiovascular
Decision Date	Apr 23, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4210
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery.

Device Story

Dual lumen 14 FR cannula; used during cardiopulmonary bypass surgery. Primary lumen infuses blood/cardioplegia; secondary lumen monitors pressure via stopcock/female luer lock. Distal tip features soft, low-pressure balloon; inflates automatically via differential infusion pressures; deflates spontaneously upon flow cessation. Includes stylet for transatrial placement in coronary sinus. Operated by surgical team in OR. Provides localized cardioplegia delivery to heart muscle; facilitates myocardial protection during bypass.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included leak testing at 10 psi (4°C and 40°C), tubing bond strength (>10 lb tensile), luer connection compliance (ANSI/HIMA MD70.1-1983), package integrity (ASTM F1140-88), and shipping/distribution vibration/drop tests.

Technological Characteristics

14 FR dual-lumen cannula; materials identical to predicate. Features distal low-pressure balloon, pressure monitoring lumen, and stylet. Luer connections meet ANSI/HIMA MD70.1-1983. Sterilization via Ethylene Oxide (Overkill Method, SAL 10⁻⁶). Packaging: Tyvek/Polymylar.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring perfusion of blood or cardioplegia solutions via the coronary sinus.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

Research Medical Retrograde Cardioplegia Cannula (K880103)

Related Devices

K964199 — CHASE CORONARY SINUS PERFUSION CANNULA · Chase Medical, Inc. · Mar 19, 1997
K991170 — RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014 · Edwards Lifesciences Research Medical · Jul 2, 1999
K123187 — RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA · Edwards Lifesciences, LLC · Feb 22, 2013
K123762 — DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF · Medtronic, Inc. · Mar 27, 2013
K253203 — Retrograde Coronary Sinus Perfusion Cannulae · Medtronic, Inc. · Feb 19, 2026

Submission Summary (Full Text)

{0} K964393 APR 23 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS ## CHASE RETROGRADE CARDIOPLEGIA CANNULA ### I. General Information A. Generic Name: Retrograde Cardioplegia Cannula B. Trade Name of Device: CHASE Retrograde Cardioplegia Cannula C. Applicant's Name and Address: CHASE Medical Inc. 1876 Firman Drive. Richardson, Texas 75081 D. Pre-market Notification Number: Not yet assigned ### II. Indications for Use The Chase Retrograde Cardioplegia Cannula is intended for use in perfusing blood or cardioplegia solutions via the coronary sinus during cardiopulmonary bypass surgery. ### III. Device Description The Chase Retrograde Cardioplegia Cannula is a dual lumen 14 FR cannula. The cannula body contains a primary lumen for infusing blood or cardioplegia solutions and a secondary pressure monitoring lumen that begins at the cannula's tip and terminates in a stopcock with a female luer lock. During infusions, differential pressures occurring within the cannula automatically inflate a soft, low pressure balloon located near the cannula's distal tip. When flow ceases, the balloon spontaneously deflates. A stylet is also provided to aid transatrial cannula placement within the coronary sinus. ### IV. Device Classification: Class II ### V. Safety and Effectiveness Substantial Equivalence: The device is substantially equivalent to the Research Medical Retrograde Cardioplegia Cannula (K880103). ### VI. Other Safety and Effectiveness Data Materials: All material are identical to the predicate device. Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ {1} # SUMMARY OF SAFETY AND EFFECTIVENESS ## Functional Testing All functional characteristics of the Chase Retrograde Cardioplegia Cannula are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition. Leak Test Requirements: No leaks at 10 psi air on CHASE device at 4°C and 40°C Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4°C and 40°C Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Tape Fittings Package Integrity: Tyvek/Polymylar passed burst test per ASTM F1140-88 Shipping & Distribution Testing: Per National Safe Transit Ass. vibration and drop tests Accelerated Aging: Two year shelf life